Back to resultsVirtual Reality as Anxiety Management Tool for Preparing Children for MR Exam (LIVE)
Primary Purpose
Claustrophobia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual Reality headset
Sponsored by
About this trial
This is an interventional other trial for Claustrophobia
Eligibility Criteria
Inclusion Criteria:
- Child from 6 to 12 years old,
- Child who will have an MRI for the first time,
- Outpatient child,
- Child dependent on a parent affiliated to or beneficiary of a social security scheme,
- Child who has received age-appropriate information on the organization of the research,
- Child whose parents (or the only parent present with parental authority) have been fully informed about the organization of the research and have signed informed consent.
Exclusion Criteria:
- Conditions that not allow the realization of a virtual MRI sceanrio or not allow to respond the scales (epilepsy, mental disorders, language, ...),
- Child with a contraindication to performing an MRI,
- Child who has benefited from another MRI simulation system before ("IRM en Jeu" for instance)
- Child's opposition to participate.
Sites / Locations
- CHRU de NancyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MRI simulation
Standard medical care
Arm Description
MRI simulation with a Virtual Reality headset
Standard medical care
Outcomes
Primary Outcome Measures
Anxiety
Anxiety measurement before and after MRI by Visual Analogue Scale between 0 and 10
Secondary Outcome Measures
Full Information
NCT ID
NCT04536116
First Posted
August 5, 2020
Last Updated
July 19, 2022
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT04536116
Brief Title
Virtual Reality as Anxiety Management Tool for Preparing Children for MR Exam
Acronym
LIVE
Official Title
EvaLuation de l'Apport de l'Irm Virtuelle Sur la qualité de la Prise en Charge Des Enfants en Irm
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
November 4, 2023 (Anticipated)
Study Completion Date
November 4, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The access to MRI examination is limited due to the duration of the acquisitions, the noise and the narrow patient space of the device. A child can, therefore, be anxious, less cooperative and move more during the acquisition, affecting the quality of the examination and the medical diagnosis. General anesthesia or sedation, may be considered to obtain diagnostic quality examinations. Our hypothesis is that a scenario as close as possible to reality to prepare children before the MR exam could reduce their anxiety, improve the quality of the exams and reduce its duration.
The purpose of this study is to evaluate the effect of virtual reality on MRI exam preparation to reduce the anxiety of children (aged from 6 to 12 years) who are referred to their first MRI exam, as compared to the current practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Claustrophobia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MRI simulation
Arm Type
Experimental
Arm Description
MRI simulation with a Virtual Reality headset
Arm Title
Standard medical care
Arm Type
No Intervention
Arm Description
Standard medical care
Intervention Type
Device
Intervention Name(s)
Virtual Reality headset
Intervention Description
MRI simulation with a Virtual Reality headset
Primary Outcome Measure Information:
Title
Anxiety
Description
Anxiety measurement before and after MRI by Visual Analogue Scale between 0 and 10
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Child from 6 to 12 years old,
Child who will have an MRI for the first time,
Outpatient child,
Child dependent on a parent affiliated to or beneficiary of a social security scheme,
Child who has received age-appropriate information on the organization of the research,
Child whose parents (or the only parent present with parental authority) have been fully informed about the organization of the research and have signed informed consent.
Exclusion Criteria:
Conditions that not allow the realization of a virtual MRI sceanrio or not allow to respond the scales (epilepsy, mental disorders, language, ...),
Child with a contraindication to performing an MRI,
Child who has benefited from another MRI simulation system before ("IRM en Jeu" for instance)
Child's opposition to participate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire BANASIAK
Phone
+33 3 83 15 42 78
Email
c.banasiak@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Coralie SERVAIT, PI
Organizational Affiliation
CHRU de Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Nancy
City
Vandoeuvre les nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Coralie SERVAIT, IP
Phone
+33 3 15 45 37
Email
c.servait@chru-nancy.fr
12. IPD Sharing Statement
Learn more about this trial
Virtual Reality as Anxiety Management Tool for Preparing Children for MR Exam
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